drugset / Trial / NCT04250259
SAMe Trial for Patients With Alcoholic Cirrhosis
Phase 2
Recruiting
196 enrolled
Indiana University
Cedars-Sinai Medical Center · collabNational Institute on Alcohol Abuse and Alcoholism (NIAAA) · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The proposed of this randomized, double blinded, placebo-controlled study is to assess the effect of SAMe compared to placebo in patients with alcoholic cirrhosis Child Class A and B. The primary objective of the study is to test relationship between SAMe (S-adenosylmethionine) supplement on liver function. The hypothesis is that SAMe supplement will improve liver function in patients with alcoholic liver disease. The improvement in liver function will lead to the reduction in all-cause mortality in patients with alcoholic cirrhosis in those who receive SAMe supplement when compared to those receiving placebo.
Timeline
- Start
- 2020-10-22
- Primary completion
- 2027-03-01
- Completion
- 2027-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | S-adenosylmethionine | Unknown | 1200 mg | — |